BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BMD WOMENS HEALTH MESH PRODUCT

    MDR report key: 8921760 · Received August 22, 2019

    Report

    Report Number
    1018233-2019-04987
    Event Type
    Injury
    Date Received
    August 22, 2019
    Report Date
    August 26, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B7 H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES IN THE ADVERSE EVENTS: ¿THE PRODUCT FAMILY FOR THIS WOMEN¿S HEALTHCARE PRODUCT IS UNKNOWN. THEREFORE, BARD IS UNABLE TO DETERMINE THE ASSOCIATED LABELING AND DFMEA TO REVIEW. ALTHOUGH THE PRODUCT FAMILY IS UNKNOWN, THE WOMEN¿S HEALTH PRODUCT IFUS ARE FOUND TO BE ADEQUATE BASED ON PAST REVIEWS." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE PATIENT¿S MEDICAL RECORDS THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED ABDOMINAL ADHESIVE DISEASE, ABDOMINAL FOREIGN BODY (PREVIOUS GORE-TEX SACROCOLPOPEXY), RECURRENT CERVICAL STUMP PROLAPSE, CYSTOCELE, RECTOCELE, ENTEROCELE, URETHROVESICAL JUNCTION HYPERMOBILITY, STRESS URINARY INCONTINENCE AND REQUIRED ONE SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717469 UNKNOWN BMD WOMENS HEALTH MESH PRODUCT UNKNOWN BMD WOMEN¿S HEALTH MESH PRODUCT FTL C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention GORTEX MYCROMESH| GORTEX MYCROMESH